cancerherbtea.com 2/26/15

Department of Health and Human Services

Public Health ServiceFood and Drug Administration

College Park, MD 20740

FEB 26, 2015

WARNING LETTER

VIA EXPRESS MAIL

Antonio Jimenez

618 Deltona Blvd

Deltona, FL 32725

RE: 446223

Dear Mr. Jimenez:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses http://www.cancerherbtea.com and http://www.anamucancerherbtea.com in December 2014 and has determined that you take orders there for the products “Anamu CancerHerb Tea Box,” “Anamu CancerHerb Tea Box with Honey,” and “Organic Bottled Tea Drinks,” which the websites promote for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the claims on your website http://www.cancerherbtea.com that provide evidence that your products are intended for use as drugs include:

On the home page:

“Cancer Herb Tea ‘You have nothing to lose but your cancer’”

“Proven to help kill the cancer cells, try out the natural herbal remedy which is successfully battling the disease!”

On the “What is Breast Cancer?” “Lung Cancer,” “What is Prostate Cancer?” “What is Colon Cancer?” and “What is Cervical Cancer?” webpages accessed from the home page:

“Cancerherbtea is a product that can help kill those cancer cells.”

On the “Recorded Studies” webpage accessed through the “What Studies Show” tab:

"[W]ater extracts and ethanol extracts of the plant retarded the growth of leukemia cells and several other strains of cancerous tumor cells … extracts had a cytotoxic effect, actually killing some of these cancer cells…”

“[E]xtracts of this Tropical Plants were toxic to leukemia and lymphoma cancer … documented anticancerous properties…”

“[A]nother in vitro study … reported that it retarded the growth of brain cancer cells.”

“Studies have also shown the herb has been used to reduce inflammation, treat infections and has played a big part as an anticancer agent”

On the “What Is Our Herbal Tea Made From?” webpage accessed through the “Cancer Fighting Herb” tab:

“Our tea and its main ingredient has been used to reduce inflammation and treat infections. But has been more importantly successful and documented to have therapeutic properties which include anti-cancerous abilities against many types of cancer, such as, Leukemia, Lymphoma, Colon, Lungs, Cervical, Prostate, and Breast cancer. The plant is also able to destroy cancer cells on the initial stages of Liver cancer, and contain Brain cancer cells.”

On the “Researchers” webpage accessed through the “Blog” tab:

“[U]sed this Tropical plant for a wide variety conditions, including arthritis,…infections, diabetes, cancer … and to induce abortion.”

“[T]he compounds in the plant were able to differentiate between normal cells and cancer cells, killing only the cancerous cells.”

Under the comments section of the “Researchers” webpage, a comment from “webmaster” states:

“[T]his is an extra ordinary [sic] product … this doesn’t only kill the cancer cells but also helps with diabetes, depression,…insomnia…”

On the “A must read vital information-literally of life and death” webpage accessed through the “Blog” tab:

“THIS IS A MUST HAVE PRODUCT TO GET RID OF YOUR CANCER CELLS!!!!!!! YOU HAVE NOTHING TO LOOSE [sic] ONLY THE CANCER…”

On the http://www.shop.cancerherbtea.com webpage accessed through the “Order Now!” tab:

“Anamu Cancer Herb Tea proven to help kill the cancer cells … This is a must have product to get rid of your cancer cells, you have nothing to loose [sic] but the cancer…”

“Also found to relieve: … Insomnia, Inflamation [sic], Infections…”

“The tea’s main ingredient has been researched … to reduce those cancer cells which is one of two of the active compounds in the drink with anti-cancerous actions.”

“[T]herapeutic properties which include anti-cancerous abilities against many types of cancer, such as, leukemia, lymphoma, and breast cancer.”

“These tropical plants are also able to destroy cancer cells on the initial stages of liver cancer, and contain brain cancer cells.”

In addition, examples of some of the claims on your promotional literature included with the purchase of your “Anamu CancerHerb Tea Box with Honey,” product that provide evidence that this product is intended for use as a drug include:

Examples of some of the claims on your website http://www.anamucancerherbtea.com that provide evidence that your products are intended for use as drugs include:

On the home page:

“Not only can the tea aid in curing the cancer and preventing re-occurrences…”

“It has also been used as a remedy to expel parasites, as an analgesic … and as an anti-inflammatory, particularly for arthritis and gastritis.”

Moreover, claims made on your Facebook page, https://www.facebook.com/pages/Cancer-Herb-Tea/504910276201061, which has a link to your website at http://www.cancerherbtea.com, where products can be purchased directly, provide further evidence that your products are intended for use as drugs:

“[H]as been used to reduce inflammation and treat infections. But has been more importantly successful and documented to have therapeutic properties which include anti-cancerous abilities against many types of cancer, such as, leukemia, lymphoma, colon, lungs, cervical, prostate, and breast cancer. The plant is also able to destroy cancer cells on the initial stages of liver cancer, and contain brain cancer cells.”

Your other Facebook page, https://www.facebook.com/anamucancerherbtea, also contains evidence of intended use in the following posts:

On December 8, 2014, you posted: “‘[A]namu’…will help patients with cancer and AIDS…anamu – Petivieria alliacea…is also efficacious as an …‘local analgesic and anti-inflamatory… used against arthritis, malaria, rheumatism…’”

On December 7, 2014, you posted: “Anamu cancer herbal tea can also help you fight type 2 Diabetes…”

In the comments section on your December 7, 2014 post: “I was diabetic now I am NOT try and see for yourself”

On May 6, 2014, you posted: “If you are looking for preventative care regarding cancer or looking to use a natural remedy for cancer, you have come to the right place. Our herbal tea which is made out of the miracle plant called Petiveria Alliacea is a natural remedy that has been scientifically proven to kill Cancer cells.”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Furthermore, your products “Anamu CancerHerb Tea Box,” “Anamu CancerHerb Tea Box with Honey,” and “Organic Bottled Tea Drinks” are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Your response should include any documentation that would assist in evaluating your corrections. If you cannot complete corrective action within fifteen working days, please explain the reason for the delay and the date by which you will make the correction.

If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, Attention: Mabel Lee (HFS-608). If you have any questions concerning this letter, please contact Ms. Lee at 240-402-0972.